Quality of research
UMC Utrecht strives for socially robust scientific research in which patient participation has an important part, and which makes use of the best and most appropriate methods. We want to make the biggest possible impact, both for our patients and for the health of society as a whole. And at a regional as well as (inter)national level. High quality and compliance with laws and regulations are the basis for this.
New rules for drug research
In 2022 the EU regulation on drug research, 536/2014 Clinical Trial Regulation (CTR) entered into force with the purpose to accelerate and simplify clinical research in the EU. Since 2023 new drug trials must be submitted via the EU portal CTIS. To support our researchers in this, we have set up a special intranet page with instructions and created a central point of contact within UMC Utrecht to launch new trials. For ongoing drug research we have drawn up instructions on how researchers can pass these on to CTIS, so that it will comply with the new rules. UMC Utrecht also joined the NFU working group on CTR.
Electronic consent procedures for research on human subjects
From July 1, 2022, it will be permitted, under certain conditions, to electronically sign the consent form for participation in scientific research under the Medical Research Involving Human Subjects Act (WMO). To be able to make use of this, we started in 2023 with a pilot with three different tools that are safe and that comply with methods approved by the law. The pilot has been extended until 2024.
Continuous development
As part of the quality assurance of research, we have an audit program in which we use tracers to scrutinize research and leadership in research (the role and responsibilities of leadership in the division).
Based on the findings from these tracers we made a number of improvements in 2023.
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To give new research workers effective support and onboarding, we developed an e-module on research policy and quality at UMC Utrecht. The e-module will become available early in 2024.
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UMC Utrecht decided to handle consent requests for research via a research management application (Vidatum) instead of submitting these by hand at the METC NedMec office. This saves researchers time and money.
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Information for our researchers on our intranet has been made clearer and we have drastically reduced the number of main topics under which they can search. We furthermore improved the accessibility of research support.
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We started the process of revising our Research Code and making it more accessible. The new code in particular includes references to the right desk, procedures and policy, with the Dutch Code of Conduct for Scientific Integrity as underlying principle. The new Research Code becomes available in 2024.
In the middle of 2023 we started with research tracers in which we looked if biobank research was being done in accordance with current laws and regulations and the policy specific to UMC Utrecht. For leadership tracers we continued to give a wider focus in 2023. On the one hand we look at the quality of leadership in research, and on the other hand, at whether UMC Utrecht ambitions are sufficiently taken into account in research. The outcomes of these tracers will be evaluated in the second half of 2024.
